Fulfilling Regulatory Requirements for
Postmarketing Submissions of Interactive
Promotional Media for Prescription Human
and Animal Drugs and Biologics
Barbara Chong, Pharm.D.
Office of Prescription Drug Promotion
Center for Drug Evaluation and Research
Food and Drug Administration
September 29, 2014
Outline
• Describe FDA’s current thinking about how firms
can fulfill the regulatory requirements for
postmarketing submissions of interactive
promotional media for their FDA-approved drug
products
• Discuss the factors taken into consideration to
determine if product communications using
interactive technologies are subject to FDA’s
postmarketing submission requirements
• Provide FDA’s recommendations for submitting
interactive promotional materials
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Definitions
• Interactive promotional media includes modern tools
and technologies that often allow for real-time
communications and interactions (e.g., blogs, microblogs,
social networking sites, online communities, and live
podcasts) that firms use to promote their drugs
• Drugs include prescription human and animal drug and
biological products
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Factors in Determining Postmarketing
Submission Requirements for Interactive
Promotional Media
• Agency considers whether the firm, or anyone
acting on its behalf, is influencing or controlling
the promotional activity or communication
• A firm is responsible for product promotional
communications on sites that are owned,
controlled, created, influenced, or operated by, or
on behalf of, the firm
• Responsible if the firm collaborates on or has
editorial, preview, or review privilege over the
content
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Factors in Determining Postmarketing
Submission Requirements for Interactive
Promotional Media
• Under certain circumstances, a firm is
responsible for promotion on third-party
sites
– Responsible if a firm has any control or
influence on the third-party site
– Responsible if a firm collaborates, or has
editorial, preview, or review privilege
– Responsible if a firm influences the
placement of its promotion within the thirdparty site
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Factors in Determining Postmarketing
Submission Requirements for Interactive
Promotional Media
• A firm is not responsible if it only provides
financial support (e.g., through an
unrestricted educational grant) and has no
control or influence on the third-party site
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Factors in Determining Postmarketing
Submission Requirements for Interactive
Promotional Media
• A firm is responsible for the content
generated by an employee or agent who is
acting on behalf of the firm to promote the
firm’s product
• FDA’s regulation of prescription drug
product promotion extends both to
promotional activities that are carried out
by the firm itself, and to promotion
conducted on the firm’s behalf
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Factors in Determining Postmarketing
Submission Requirements for Interactive
Promotional Media
• For example, if an employee or agent of a
firm, such as a medical science liaison or
paid speaker (e.g., a key opinion leader)
acting on the firm’s behalf, comments on
a third-party site about the firm’s product,
the firm is responsible for the content its
employee or agent provides
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Factors in Determining Postmarketing
Submission Requirements for Interactive
Promotional Media
• A firm generally is not responsible for UGC
that is truly independent of the firm (i.e., is
not produced by, or on behalf of, or prompted
by the firm in any particular)
• FDA will not ordinarily view UGC on firmowned or firm-controlled venues as
promotional content on behalf of the firm as
long as the user has no affiliation with the
firm and the firm had no influence on the
UGC
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Recommendations
• FDA recommends that a firm be
transparent in disclosing its involvement
on a site by clearly identifying the content
and communications of its employees or
agents acting on behalf of the firm
– This could be achieved by inclusion of
the firm's identifier (e.g., name or logo)
as part of the communication
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Submission of Sites for Which a
Firm is Responsible
• At the time of initial display, submit in its
entirety all sites for which a firm is
responsible on Form FDA 2253 or Form
FDA 2301
– Submit the comprehensive static product
website with the addition of the interactive or
real-time components
• Include annotations to describe the parts
that are interactive and allow for real-time
communications
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Submission of Sites for Which a
Firm is Responsible
• Any subsequent changes should be
annotated and resubmitted at the time of
initial display (i.e., resubmission)
• Provide a cross-reference by noting the
submission date of the most recent
version of the site in the comments
section of the form
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Submission of Sites for Which a
Firm is Responsible
• After the initial submission or resubmission, if
the site is non-restricted and remains
unchanged other than displaying real-time
information, the firm can submit a monthly
updated listing of the site that does not
include screenshots or other visual
representations of the actual interactive or
real-time communication
13
Submission of Third-Party Sites in
Which a Firm’s Participation is Limited
to Interactive Communications
• Submit the home page of the third-party
site, along with the interactive page within
the third-party site and the firm’s first
communication at the time of initial
display
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Submission of Third-Party Sites in
Which a Firm’s Participation is Limited
to Interactive Communications
• After the initial submission, if the firm
remains an active participant on the thirdparty site, and that site is non-restricted,
the firm can submit a monthly updated
listing of the site that does not include
screenshots or other visual
representations of the actual interactive or
real-time communication
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Recommendations for Monthly
Updates for Non-Restricted Sites
• Once every month, submit an updated
listing of all non-restricted sites for which
firm is responsible or in which it remains
an active participant and that include
interactive or real-time communications
• Multiple sites and the corresponding
documents can be submitted with a single
Form FDA 2253 or Form FDA 2301
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Recommendations for Monthly
Updates for Non-Restricted Sites
• Include a separate document for each
site which includes:
– Site name
– URL
– Date range
– Cross-reference to the date of the most
recent submission of the site
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Recommendations for Monthly
Updates for Non-Restricted Sites
• Screenshots or other visual
representations of the actual interactive or
real-time communications need not be
submitted with the monthly updates if the
site is non-restricted
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Recommendations for Monthly
Updates for Restricted Sites
• If a site has restricted access (e.g., is
password protected or a subscription is
required) submit all content related to the
discussion to adequately provide context
to facilitate the review
• Screenshots or other visual
representations of the actual site,
including the interactive or real-time
communications, should be submitted
monthly on Form FDA 2253 or Form FDA
2301
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